K251591
- 510(k) number
- K251591
- Device name
- Holter ECG and ABP system (HolterABP)
- Applicant
- Edan Instruments, Inc. CN
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2026-02-09
- Date received
- 2025-05-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K251591.pdf
Official FDA record: K251591
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.